Requirements: English
Company: GlaxoSmithKline
Region: Warsaw , Masovian Voivodeship
Site Name: Warsaw
Posted Date: Jan 23 2025
Director, Medical Review Scientist (FTC)
Fixed Term Contract 12 months
GSK is expanding the Oncology Clinical Development organization and we are seeking experienced professionals to join our exciting journey. GSK Oncology has a commitment to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer.
Oncology Clinical Development is a specialized Clinical Trial Medical Review Team (CTMRT) that is wholly integrated within the global Oncology Clinical Development function and composed of Medical Review (MR) Scientists and MR Physicians. CTMRT staff, composed of Clinical Scientists and Physicians, integrates seamlessly with the core study team and be highly valued Medical Review subject matter experts (SMEs) with a focus on excellence in content and delivery of instream medical review with the goal of delivering a complete, robust, and medically accurate data package. The CTMRT works with fellow Oncology Clinical Development staff from a centralized work location that has close ties with other functions located at the local site.
As a Director Medical Review Scientist you are responsible for performing medical review activities across multiple oncology studies with a wide range of therapeutic modalities and tumor types, as well as mentoring Associate Director MR Scientists.
This role is based at the GSK Warsaw, Poland site. You can learn more about the GSK Poland Hub here.
This role gives YOU the opportunity to work on key activities to progress YOUR career, these
responsibilities include some of the following:
- Responsible for the medical consistency and robustness of clinical data that cannot be processed by computerized means.
- Iterative, in-stream, standardized data review that employs medical judgment, with intent to ensure data accurately and completely reflect the clinical course of participant(s) in the study.
- Review and contribute to study-related documents such as protocols, medical monitoring plans, statistical analysis plans, data management plan, eCRFs, eCRF completion guidelines, database edit checks, risk-based monitoring plans, etc. May contribute to site training activities and supporting the study team and CRO personnel regarding all MR-related aspects of the trial.
- During study set-up phase, in collaboration with the Data Management and Clinical Development team, the MR Scientist develops a Medical Review Plan (MRP) for the study, which details the scope of the medical review and appropriate timelines s/he performs on the study data. This review requires a holistic approach within and across study participants, and a deep understanding of the study protocol, patient population, and medical knowledge. The medical review will encompass participant eligibility, protocol adherence, medical consistency, safety checks, as well as efficacy checks when appropriate. The MRP is a living document and will be updated and adapted as the study progresses, in collaboration with the Data Management and Clinical Development teams.
- Assist in setting up medical review tools that support medical review throughout the study, such as reviewing the specifications, identifying critical variables, and performing user acceptance testing (UAT).
- During the data collection phase, the MR Scientist executes medical review for which s/he is responsible as defined in the MRP during the set-up phase.
- Collaborate with the Centralized Monitoring team to identify key study risks based on the iterative medical review.
- Support medical coders to ensure consistency and accuracy of adverse events, medical history, and concomitant medication coding.
- Review statistical program outputs (i.e., tables, figures, and listings or TFLs) during study to identify inconsistencies in data capture and areas that need to be addressed by the CTMRT.
- Accountable to the Clinical Study Team for: review of medical-related protocol deviations, raising and responding to medical queries in the database, analysis of trends for data inconsistencies and flagging areas that require additional site training, etc. May be responsible for developing site training materials to address those issues.
- Participate and contribute to weekly core study team meetings and update the teams on the status of medical review, trend analysis, etc.
- Identifies program, trial or data risks, creates, and implements mitigation strategies in collaboration with the Clinical Study Team as appropriate.
- Support the Data Management team in ensuring the eCRFs and eCRF completion guidelines accurately reflect the patient population under study and the scope of the protocol.
- Require a close collaboration with the studys Clin